MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys tsh ver.2 and the elecsys ft4 iii assay on two cobas e 801 analytical unit analyzers.No questionable results were reported outside of the laboratory.This medwatch will apply to the tsh v 2 assay.Please refer to the medwatch with.Patient identifier (b)(6) for information related to the ft4 assay.Refer to the attachment for all patient data.The questionable values are highlighted.The patient sample was initially tested on the customer's e 801 analyzer on (b)(6) 2023 and was repeated using the abbott architect.The sample was provided for investigation, where it was tested using a second e 801 analyzer on (b)(6) 2023.The sample was also repeated using the fujirebio lumioulse analyzer on (b)(6) 2023.The serial number of the customer's e 801 analyzer was requested, but not provided.The tsh v 2 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh v 2 reagent lot number 653314, with an expiration date of 31-dec-2023 was used on this analyzer.

Manufacturer Narrative

The investigation determined the differences in values relates to the differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation could not identify a product problem.

• Brand Name: ELECSYS TSH
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16706429
• MDR Text Key: 312943794
• Report Number: 1823260-2023-01146
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: ASKU, 653314
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female